In response to the COVID-19 outbreak FDA has postponed most foreign and all routine domestic inspections through April, effective immediately. The agency will still consider mission-critical foreign inspections on a case-by-case basis.
In keeping with the White House Coronavirus Task Force and cross-government guidance, FDA has directed all its eligible employees to begin teleworking, and has temporarily postponed all domestic routine surveillance facility inspections, both for the health and well-being of inspectors, and because of industry concerns about visitors. However, domestic for-cause inspection assignments will continue to be evaluated and will proceed if mission-critical; FDA will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products; and those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, will continue to perform their work.
The foreign facility decision was made because of the State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees; CDC’s travel recommendations; access restrictions imposed on foreign visitors by certain countries; guidance from the Office of Personnel Management; and the health and safety of its employees. As an interim measure, FDA is denying entry of unsafe products into the U.S., conducting physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records “in advance of or in lieu of” on-site drug inspections. The actions are part of the FDA’s multi-pronged and risk-based approach to ensuring quality and comply with federal laws and regulations. Additionally,
FDA is working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate regulation, such as first-time importers unfamiliar with requirements or repeat offenders trying to skirt the law.
Using its risk-based import screening tool, PREDICT, FDA will focus its examinations and sample collections based on heightened concerns of specific products, with PREDICT adjusting COVID-19 risk scores as needed.
It is watching for indications of port shopping or cargo diversion and will continue oversight of shipments through potentially higher-risk venues.
The agency also can refuse admission of products that fail sample testing or may violate other applicable legal requirements.
As COVID-19 remains a dynamic situation, FDA will continue to leverage all available authorities to ensure the integrity of the products it regulates, both domestic and foreign; assess and calibrate its approach as needed; and resume inspections as soon as feasible.
Although FDA will not be routinely inspecting facilities, it is critical that we all continue to focus on routine food safety regulations and standards while we work through the impacts of COVID-19. Should you need assistance with your food safety or COVID-19 protection practices, give TAG a call. We have experts to help guide you through these difficult times.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com